Comparison of intervals between colonoscopic examinations in Familial Colorectal Cancer: The Dutch FAmilial ColorecTal cancer Surveillance study (the FACTS study) Group
| ISRCTN | ISRCTN82767023 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82767023 |
| Secondary identifying numbers | P02.070 |
- Submission date
- 26/11/2014
- Registration date
- 05/12/2014
- Last edited
- 05/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Five to ten percent of all cases of colorectal cancer (CRC) are caused by a combination of hereditary and environmental factors; these cases are collectively referred to as ‘familial CRC’. Colonoscopic surveillance is recommended for individuals with familial CRC. However, the appropriate screening interval (between colonoscopic examinations) has not yet been determined. The aim of this study was to compare a 3-year with a 6-year screening interval.
Who can participate?
500 adults aged 45-65, with a family history of CRC.
What does the study involve?
Participants will get a colonoscopy at enrollment in the study to determine if they have certain types of polyps (adenomas) that could become cancerous. These will be removed. If participants have 3 or more adenomas, next colonoscopies will be scheduled after 3 and 6 years. If participants have 0, 1 or 2 adenomas, they are randomly assigned to 2 study groups: follow-up colonoscopy in group A will be scheduled after 6 years, while in group B follow-up colonoscopies will be scheduled after 3 and 6 years. Comparisons between the groups A and B will be made for the presence of advanced adenomas (which have a higher potential of becoming cancerous but are not yet cancerous). This will help us define the interval to recommend between 2 colonoscopies.
What are the possible benefits and risks of participating?
The possible benefit for participants is that, if found at colonoscopy, adenomas from the colon are removed before cancer has developed. This study will also show for this type of population with a family history of CRC whether a 6-yearly interval between examinations/colonoscopies is safe (instead of having a colonoscopy every 3 years).
Possible risks are complications of colonoscopy. However, these risks of perforation and bleeding are very low. Participants are instructed when to contact the hospital again. Also, when the procedure was difficult or complicated, participants are kept under observation in hospital after the procedure (and if needed, treated).
Where is the study run from?
The FACTS study has been set up by the Leiden University Medical Center. Colonoscopies are also performed at collaborating national hospitals in the Netherlands.
When is the study starting and how long is it expected to run for?
Recruitment took place in 2002-2007. The study run for 6 years after inclusion of the last participant in 2007 until mid-2013.
Who is funding the study?
Netherlands Organisation for Health Research and Development.
Who is the main contact?
Professor Hans Vasen
hfavasen@stoet.nl
Contact information
Scientific
Rijnsburgerweg 10
Leiden
2333 AA
Netherlands
Study information
| Study design | Multicentre randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomized comparison of surveillance intervals in Familial Colorectal Cancer: The Dutch FAmilial ColorecTal cancer Surveillance study (the FACTS study) Group |
| Study acronym | FACTS |
| Study objectives | The aim of this randomized trial was to compare a 3-year with a 6-year screening interval. The hypothesis was that a 6-year screening interval is safe. |
| Ethics approval(s) | Committee of Medical Ethics at the Leiden University Medical Center, 22/08/2002, ref: P02.070 |
| Health condition(s) or problem(s) studied | Colorectal cancer (CRC) |
| Intervention | Based on the results of the baseline colonoscopy, patients were assigned to different study groups (group A and B). Patients who had 3 or more adenomatous polyps at baseline were excluded and were scheduled for a follow-up colonoscopy at 3 years. Patients with 0, 1 or 2 adenomatous polyps at baseline were randomized into two groups: group A underwent colonoscopy at 6 years, while group B underwent follow-up colonoscopies at 3 and 6 years. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Presence of adenoma with advanced pathology (AAP), defined as an adenoma with either high grade dysplasia, (tubulo)villous architecture or a size ≥ 1 cm in diameter. This is measured at timepoint 6 years in group A, and at timepoints 3 and 6 years in group B. Polyps are removed during colonoscopies at these timepoints and are revised by one pathologist for characteristics of AAP. |
| Secondary outcome measures | Presence of adenomas. This is measured at timepoint 6 years in group A, and at timepoints 3 and 6 years in group B. Polyps are removed during colonoscopies at these timepoints and are revised by one pathologist for characteristics of adenomas. |
| Overall study start date | 01/01/2002 |
| Completion date | 01/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 500 |
| Total final enrolment | 528 |
| Key inclusion criteria | 1. Individuals aged between 45 and 65 years, 2. A positive family history for colorectal cancer (CRC), i.e., one first-degree relative (FDR) diagnosed with CRC <50 years, or two FDRs diagnosed with CRC at any age. Subjects were excluded if they had 3 or more adenomas at baseline colonoscopy, while those with 0-2 adenomas were randomized into two groups: A) colonoscopy at 6 years and B) colonoscopy at 3 and 6 years. |
| Key exclusion criteria | 1. Additional first or second-degree relatives with CRC 2. A personal history of inflammatory bowel disease 3. Previous colorectal surgery, 4. A first-degree relative with CRC with known microsatellite instability or strong suspicion of Lynch syndrome (e.g., combination of CRC and endometrial cancer). |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 30/08/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
2300 RC
Netherlands
3430 EM
Netherlands
2300 RD
Netherlands
9700 RM
Netherlands
9700 RB
Netherlands
8000 GK
Netherlands
6500 HB
Netherlands
4800 RL
Netherlands
5600 PD
Netherlands
5602 ZA
Netherlands
1800 AM
Netherlands
2600 GA
Netherlands
7800 RA
Netherlands
Sponsor information
Hospital/treatment centre
Albinusdreef 2
Leiden
2333 ZA
Netherlands
| Website | https://www.lumc.nl/ |
|---|---|
"ROR" |
https://ror.org/05xvt9f17 |
Funders
Funder type
Research organisation
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/02/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | We would like to publish our results on a short term in a journal in general medicine, or specifically in the field of gastroenterology. Also, our plan is to submit the abstract to conferences (gastroenterology, hereditary tumours in the gastrointestinal tract). |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/12/2015 | 05/03/2019 | Yes | No |
Editorial Notes
05/03/2019: Publication reference added.
